STAT+: China tightens the reins on clinical trials, even as the U.S. looks for ways to replicate its rival’s speed

For years, U.S. scientists and biotech companies have watched warily as China has made strides onto the global stage, overtaking them in research spending, patent applications, and clinical trials. To many observers, it has been a sign that the U.S. needs to urgently modernize a lumbering clinical trial and regulatory system. But now, a key driver of China’s roaring biomedical engine — one that many researchers believe the U.S. should replicate — is being fine-tuned, and a system that was credited with supporting the country’s wild success has come under scrutiny. That system has been fueled by what are known as investigator-initiated trials, or ITTs, in which researchers were long permitted to launch clinical trials without sign-off from the National Medical Products Administration, China’s equivalent of the Food and Drug Administration, and without the rigorous review that would otherwise come with it. The studies have allowed China to speed up the translation of medical research, encourage physicians to become a part of the country’s drug innovation engine, and help produce billions of dollars in sales of newly approved medicines.They also appear to have come at a price, raising questions about patient safety, a lack of transparency, and the use of intellectual property. STAT+ Exclusive Story Already have an account? Log in This article is exclusive to STAT+ subscribers Unlock this article — plus daily coverage and analysis of the biotech sector — by subscribing to STAT+. Already have an account? Log in View All Plans To read the rest of this story subscribe to STAT+. Subscribe